About the role
Description CONTEXT A growing medical device company specializing in steerable cardiac catheters is seeking an experienced Manufacturing Process Development & Scale‑Up Consultant. Reporting to the CTO (Head of R&D & Operations), the consultant will lead efforts to transition low-volume manufacturing to outsourced, scalable production, including site selection, knowledge transfer, pilot implementation, and full-scale launch. Ideal candidates bring big-company, multi-step catheter manufacturing expertise and a proven track record in outsourced medical device scale-up
Responsibilities DUTIES/EXPECTATIONS OF THIS ROLE Outsourced Manufacturer Selection & Onboarding
- Identify and evaluate potential US and global manufacturing partners capable of scaling catheter production
- Conduct site visits, due diligence, and comparative assessments for capacity, quality systems, and regulatory readiness
- Support contracting, MSA negotiation, and alignment of manufacturing scope
Knowledge Transfer & Pilot Program Design
- Lead knowledge transfer sessions, ensuring clear documentation of current catheter assembly processes
- Develop and manage pilot manufacturing protocols, including tolerances, throughput targets, and quality measures
- Set success metrics and advance-to-production criteria for pilot outcomes
Scale‑Up Planning & Execution
- Architect scalability roadmap: process flows, capacity planning, supply chain logistics, and automation potential
- Integrate quality systems, regulatory compliance, and process validation into scale-up transition
- Oversee supplier onboarding, staff training, and site readiness for production ramp
Continuous Improvement & Operations Enablement
- Implement statistical process control (SPC), lean manufacturing practices, and quality analytics
- Monitor operational KPIs during pilot and early production phases → adjust protocols for improvement
- Enable cross-functional collaboration: Manufacturing, Quality, Supply Chain, R&D, and external partners
Experience Requirements MUST HAVES – QUALIFICATION SUMMARY
- 10+ years in manufacturing process development, scale-up, and transfer in regulated medical device environments, preferably in catheters or steerable cardiovascular devices
- Proven success managing outsourced manufacturing startups, from pilot through annual production volume (~10k units/year)
- Strong familiarity with multi-step catheter assembly processes: extrusion, braiding, bonding, coating, final assembly
- Experience conducting site qualification and knowledge transfers, driving pilot implementation and scale
- Demonstrated ability to operate with objectivity and autonomy, ideal for high-ambiguity, scaling environments
- Background at a large med-tech or medical device OEM
- Expertise in lean manufacturing, SPC, ISO 13485, FDA/CE regulatory landscapes
- Advanced degree in Engineering, Manufacturing, or related discipline
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